Product/Service

Early Phase

Source: PAREXEL International

Parexel

Many biopharmaceutical companies are exploring new types of strategic partnerships to help them save time and money during the most challenging and costly stage of product development – pivotal Phase IIb/III clinical trials.

Many biopharmaceutical companies are exploring new types of strategic partnerships to help them save time and money during the most challenging and costly stage of product development – pivotal Phase IIb/III clinical trials. By working with the right strategic partner for these vital studies, biopharmaceutical companies can greatly increase efficiency by focusing their internal resources on the highest priorities – such as discovery research and product marketing – while relying on their partners for a broad array of specialized knowledge and infrastructure, such as in-depth therapeutic-area expertise, clinical trial experience, global patient and investigator resources, and regulatory knowledge.

As one of world’s largest CROs, PAREXEL is right where you need us with the global experience, infrastructure, knowledge, and technology to conduct pivotal clinical trials of any size. Our Phase IIb/III resources span the Americas, Europe, Africa, and Asia, helping our partners access global markets and diverse patient populations, while lowering the cost of conducting clinical research.

Whatever the size of your study, we can plan and manage your pivotal trials from beginning to end, including: study design, protocol development, site and patient recruitment, clinical monitoring, database design, document management, clinical logistics, and medical writing. PAREXEL works closely with investigators, patients, and sites to ensure that all protocols are followed and all deadlines are met – reducing the costs, risks, and delays of conducting your trials.

We have enhanced our services in number of vital areas to improve our support of global Phase IIb/III trials, including:

  • Study start-up and patient recruitment – PAREXEL's unique “predictive management” model focuses on using improved data assets to address the growing problem of patient recruitment. This innovative approach integrates all the activities and milestones of trial start-up – such as protocol development, site selection, investigator recruitment, first-patient-in, and last-patient-in – and applies an adaptive escalation process to ensure that our trials begin on time, even as conditions change.
  • eClinical technologies and data management – PAREXEL’s technology subsidiary, Perceptive Informatics, is the industry’s leading eClinical solutions provider, with a broad array of innovative products that increase trial efficiency and improve data management, including:
    • ClinPhone®, the world’s leading Randomization and
    • Trial Supply Management (RTSM) system
    • Clinical Trial Management Systems (CTMS)
    • Electronic Data Capture (EDC)
    • Electronic Patient Reported Outcomes (ePRO) systems
    • Advanced medical imaging technology
  • Therapeutic area expertise – PAREXEL's medical directors and scientists have extensive experience in all the major therapeutic areas, with particular expertise in cardiovascular diseases, central nervous system (CNS) disorders, infectious diseases, and oncology. Other areas of significant therapeutic expertise include respiratory diseases, metabolic disorders, immunology, and rheumatology.
  • Site management – Our experience conducting thousands of clinical trials has yielded proven best practices and trials metrics that allow us to efficiently and effectively monitor site operations anywhere in the world. Equally important, PAREXEL has experienced local personnel in 54 countries who understand the medical, cultural, and regulatory differences at global trial sites, and can communicate directly with sites in their own languages.
  • Medical writing – PAREXEL offers a wide variety of global medical writing services to support your pivotal trials, including clinical development plans, protocols, informed consent forms, and investigator brochures.
  • Clinical logistics services – We can provide comprehensive clinical logistics services to manage all aspects of clinical trial supplies, lab services, and ancillary supplies – services that cut logistics costs, reduce waste, and improve regulatory and protocol compliance.